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Trial of Alvimopan in Major Spine Surgery

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ClinicalTrials.gov Identifier: NCT02789111
Recruitment Status : Unknown
Verified May 2018 by Bhiken I. Naik, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : June 2, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bhiken I. Naik, MD, University of Virginia

Brief Summary:
The Investigator has chosen to study the reconstructive spinal surgery patient population because it is believed that the use of alvimopan in these patients at the University of Virginia will give the scientific community significant insight into the broader applicability of this drug into other surgical populations, the impact of this drug on the perception of pain (as opposed to simply the consumption of opioids), and its impact on total hospital charges, resource utilization, and functional outcomes.

Condition or disease Intervention/treatment Phase
Constipation Drug: Alvimopan Drug: Placebo Phase 4

Detailed Description:

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects. Such side effects may include urinary retention, altered mental status, depressed respiratory drive, and constipation, and may lead to reduced nutritional intake in the postoperative period. Importantly, post-operative nutrition may impact the incidence of complications following spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the gastrointestinal complications of perioperative systemic opioid administration.

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects including constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is used to help the bowel recover more quickly in patients who are having bowel surgery, so that they can eat solid foods and have regular bowel movements. Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.

The purpose of this study is to determine if the use of alvimopan in major spine surgery reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive spinal surgery patients, researchers hope to give the scientific community insight into the broader use of this drug in other surgical populations, as well as gathering information on the impact of hospital charges and overall post-operative patient satisfaction.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alvimopan

Arm Intervention/treatment
Active Comparator: Alvimopan
12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Drug: Alvimopan
Alviimopan 12 mg twice daily up to 15 doses
Other Name: Entereg

Placebo Comparator: Placebo
Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Drug: Placebo
Placebo twice daily up to 15 doses




Primary Outcome Measures :
  1. time to first bowel movement [ Time Frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement ]
    time to first bowel movement


Secondary Outcome Measures :
  1. time to resumption of PO intake [ Time Frame: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake ]
    time to resumption of PO intake



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major spine surgery scheduled as part of clinical care
  • 18-80 years

Exclusion Criteria:

  • More than three doses of any opioid within one week of surgery
  • Pregnancy
  • Prisoners
  • Unable to provide consent
  • Emergency surgery
  • Chronic kidney disease stage 5 (GFR < 15 ml/min)
  • Severe hepatic impairment
  • Recent myocardial infarction (within the last 3 months)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789111


Contacts
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Contact: Marcia E Birk, RN 434-924-2283 meb2w@virginnia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Marcia E Birk, RN    434-924-2283    meb2w@virginia.edu   
Contact: Bhiken Naik, MBBCh    434-924-2283    bin4n@virginia.edu   
Principal Investigator: Bhiken Naik, MBBCh         
Sponsors and Collaborators
University of Virginia
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Bhiken Naik, MBBCh Anesthesiology Attending
Publications:

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Responsible Party: Bhiken I. Naik, MD, Anesthesiology attending, University of Virginia
ClinicalTrials.gov Identifier: NCT02789111    
Other Study ID Numbers: 18781
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Alvimopan
Gastrointestinal Agents